SAN DIEGO, July 18, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the launch of a new sprinkle formulation of INGREZZA® (valbenazine) capsules, the #1 prescribed vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA® SPRINKLE (valbenazine) capsules is now available through the same network of specialty and local affiliated pharmacies that distribute INGREZZA..

圣地亚哥，2024年7月18日/PRNewswire/--Neurocrine Biosciences，Inc.（纳斯达克：NBIX）今天宣布推出INGREZZA®（缬苯那嗪）胶囊的新型喷雾剂配方，这是一种#1处方的囊泡单胺转运蛋白2（VMAT2）抑制剂，用于治疗与亨廷顿舞蹈病相关的迟发性运动障碍和舞蹈病。INGREZZA®Sprink（缬苯那嗪）胶囊现在可通过分销INGREZZA的专业和当地附属药店的同一网络获得。。

'Only INGREZZA offers a sprinkle formulation to ease administration for individuals living with tardive dyskinesia or Huntington's disease chorea, who often have difficulty swallowing pills,' said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. 'We wanted to provide this new option to patients and their caregivers who want the benefit of treatment with INGREZZA without the challenge of swallowing a capsule.'.

Neurocrine Biosciences首席医疗官EiryW.Roberts医学博士说：“只有INGREZZA提供了一种喷雾剂配方，可以缓解患有迟发性运动障碍或亨廷顿舞蹈病的患者的服用，这些患者通常吞咽药片有困难。”我们想为那些希望接受英格瑞扎治疗而不需要吞咽胶囊的患者及其护理人员提供这种新的选择。”。

INGREZZA and INGREZZA SPRINKLE offer simple dosing that's always one capsule, once daily with no complex dose adjustments to get to an effective dose.1 Only INGREZZA and INGREZZA SPRINKLE offer a therapeutic dose from day one.1 INGREZZA SPRINKLE offers the same three simple and effective dosing options (40 mg, 60 mg and 80 mg) as INGREZZA, which can be adjusted by a healthcare provider based on patient response and tolerability.1.

INGREZZA和INGREZZA SPRINKLE提供简单的剂量，总是一粒胶囊，每天一次，没有复杂的剂量调整以达到有效剂量。1只有INGREZZA和INGREZZA SPRINKLE从第一天开始提供治疗剂量。1 INGREZZA SPRINKLE提供与INGREZZA相同的三种简单有效的剂量选择（40毫克，60毫克和80毫克），可以由医疗保健提供者根据患者的反应和耐受性进行调整。1。

The INGREZZA SPRINKLE capsule is easy to open and the contents (granules) can be sprinkled on soft food, such as applesauce, yogurt or pudding, for oral administration. Proper preparation and administration of INGREZZA SPRINKLE is described in the Instructions for Use.

INGREZZA Spread胶囊易于打开，内含物（颗粒）可以撒在软食品上，如苹果酱、酸奶或布丁，用于口服。使用说明中描述了INGREZZA Spread的正确制备和管理。

'Most people living with chorea associated with Huntington's disease will experience swallowing issues,' said Katie Jackson, President, Help 4 HD International. 'The availability of a treatment for chorea that can be easily sprinkled onto food is very helpful in reducing the burden of taking a pill for these individuals and their caregivers, especially as the disease progresses.'.

Help 4 HD International总裁凯蒂·杰克逊（KatieJackson）说，大多数患有亨廷顿舞蹈病的人都会出现吞咽问题可以很容易地洒在食物上的舞蹈病治疗方法的可用性对于减轻这些人及其护理人员服用避孕药的负担非常有帮助，尤其是随着疾病的进展。”。

Taking pills can also be difficult for people living with TD.2 In a survey of patients with TD experiencing moderate-to-severe involuntary movement symptoms (n = 250), 37% reported that their movements impacted their ability to eat and drink.2*†

TD患者服用药物也可能很困难。2在一项对TD患者进行的中度至重度不自主运动症状（n=250）的调查中，37%的患者报告说，他们的运动影响了他们的饮食能力。2*†

Neurocrine Biosciences received U.S. Food and Drug Administration approval of INGREZZA SPRINKLE on April 30 of this year. The approval was based on chemistry, manufacturing and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared with INGREZZA capsules..

Neurocrine Biosciences于今年4月30日获得了美国食品和药物管理局对INGREZZA Sprink的批准。该批准基于化学，制造和控制信息和数据，证明了英格瑞扎喷雾剂与英格瑞扎胶囊相比的生物等效性和耐受性。。

The cost of INGREZZA SPRINKLE is equivalent to INGREZZA. The INBRACE® Support Program provided by Neurocrine Biosciences helps patients who are prescribed INGREZZA or INGREZZA SPRINKLE by assisting with product support and prescription fulfillment. Patients with commercial insurance may be eligible for copay assistance, and patients with no prescription coverage who also lack the financial resources to pay for their medicine may be eligible for participation in the patient assistance program.

INGREZZA Spread的成本相当于INGREZZA。Neurocrine Biosciences提供的INBRACE®支持计划通过协助产品支持和处方履行，帮助处方INGREZZA或INGREZZA Sprink的患者。拥有商业保险的患者可能有资格获得copay援助，没有处方保险的患者也缺乏支付药物的财政资源，可能有资格参加患者援助计划。

Most patients pay $10 or less out-of-pocket for INGREZZA. For more information, patients may visit INBRACESupportProgram.com/INGREZZAPatient/..

大多数患者为INGREZZA自付10美元或更少。有关更多信息，患者可以访问INBRACESupportProgram.com/INGREZZAPatient/。。

About Tardive Dyskinesia (TD)Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain.

关于迟发性运动障碍（TD）迟发性运动障碍（TD）是一种运动障碍，其特征是面部，躯干和/或其他身体部位的不可控制，异常和重复运动，这可能会对患者产生破坏性和负面影响。。

Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement.

服用通常用于治疗重性抑郁症、躁郁症、精神分裂症和分裂情感障碍等精神疾病的抗精神病药物以及其他用于治疗胃肠道疾病的处方药（甲氧氯普胺和丙氯拉嗪）与TD有关。对于TD患者，这些治疗被认为会导致大脑控制运动的区域产生不规则的多巴胺信号传导。

The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S..

TD的症状可能很严重，通常是持续性和不可逆的。据估计，TD将影响美国约60万人。。

About Chorea Associated with Huntington's Disease (HD)Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period.

关于与亨廷顿舞蹈病（HD）相关的舞蹈病亨廷顿舞蹈病（HD）是一种遗传性进行性神经退行性疾病，其中大脑中某些神经元的丧失会导致运动，认知和精神症状。症状通常出现在30至50岁之间，并在10至25年内恶化。

Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease..

大多数HD患者都会出现舞蹈病，这是一种异常的非自愿运动障碍，其特征是不规则和不可预测的运动。舞蹈病会影响身体的各个部位，并干扰运动协调，步态，吞咽和言语。据估计，HD在美国约影响41000名成年人，其中超过200000人有遗传疾病的风险。。

About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) CapsulesINGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD) that is always one capsule, once daily with no complex dose adjustments to get to an effective dose.

关于INGREZZA®（缬苯那嗪）胶囊和INGREZZA®Spread（缬苯那嗪）胶囊INGREZZA是一种选择性囊泡单胺转运蛋白2（VMAT2）抑制剂，经美国食品和药物管理局批准用于治疗成人迟发性运动障碍和治疗与亨廷顿舞蹈病（HD）相关的舞蹈病，它总是一粒胶囊，每天一次，没有复杂的剂量调整以达到有效剂量。

Only INGREZZA offers a therapeutic dose from day one..

只有INGREZZA从第一天开始提供治疗剂量。。

INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement.

由Neurocrine Biosciences开发的INGREZZA选择性抑制VMAT2，对VMAT1，多巴胺能（包括D2），血清素能，肾上腺素能，组胺能或毒蕈碱受体没有明显的结合亲和力。虽然INGREZZA治疗TD和HD舞蹈病的具体方法尚不完全清楚，但INGREZZA的独特之处在于它选择性和特异性地靶向VMAT2以抑制多巴胺的释放，多巴胺是大脑中有助于控制运动的化学物质。

INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements..

英格瑞扎被认为可以减少额外的多巴胺信号传导，从而减少无法控制的运动。。

INGREZZA can be taken as one capsule, once daily together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA® SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill.

英格瑞扎可以作为一粒胶囊服用，每天一次，与抗精神病药或抗抑郁药等最稳定的心理健康方案一起服用。只有INGREZZA才能为吞咽困难、吞咽困难或不喜欢吞咽药丸的患者提供喷雾配方INGREZZA®Spline的益处。

INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules..

。。

Important Information

重要信息

Approved Uses

批准的用途

INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:

INGREZZA®（缬苯那嗪）胶囊或INGREZZA®Spread（缬苯那嗪）胶囊是用于治疗成人的处方药：

movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

面部、舌头或其他身体部位无法控制的运动（迟发性运动障碍）。

involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.

亨廷顿舞蹈病的非自愿运动（舞蹈病）。。

It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.

目前尚不清楚英格瑞莎或英格瑞莎喷雾剂对儿童是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

VMAT2抑制剂，包括INGREZZA和INGREZZA Sprink，可对亨廷顿舞蹈病患者产生严重的副作用，包括：抑郁症，自杀念头或自杀行为。如果你患有亨廷顿舞蹈症和抑郁症（患有未经治疗的抑郁症或药物控制不佳的抑郁症）或有自杀念头，请在开始服用英格丽萨或英格丽萨喷雾剂之前告诉你的医疗保健提供者。

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself..

密切注意情绪、行为、思想或感觉的任何变化，尤其是突然变化。当INGREZZA或INGREZZA喷洒开始以及剂量改变时，这一点尤为重要。如果你情绪低落，情绪或行为发生异常变化，或者有伤害自己的想法，请立即致电你的医疗保健提供者。。

Do not take INGREZZA or INGREZZA SPRINKLE if you:

如果您有以下情况，请勿服用INGREZZA或INGREZZA喷雾剂：

are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.

对缬苯那嗪或英格瑞扎或英格瑞扎喷雾中的任何成分过敏。

INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:

INGREZZA或INGREZZA Sprink会引起严重的副作用，包括：

Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives).

过敏反应。过敏反应，包括导致突然肿胀的过敏反应，称为血管性水肿，可能发生在服用第一剂后或服用多剂英格丽莎或英格丽莎喷雾剂后。过敏反应和血管性水肿的体征和症状包括：呼吸困难或呼吸急促，面部，嘴唇，眼睑，舌头或喉咙或皮肤其他部位肿胀，吞咽困难或皮疹，包括皮肤上凸起，发痒的红色区域（荨麻疹）。

Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema..

喉咙肿胀可能危及生命，并可能导致死亡。。。

Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE..

嗜睡和疲倦可能导致反应时间缓慢（嗜睡和镇静）。在你知道英格瑞莎或英格瑞莎洒水对你的影响之前，不要开车或操作危险的机器。。。

Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint..

心律问题（QT延长）。英格利扎或英格利扎喷雾剂可能会导致心律问题，称为QT延长。如果您在使用英格瑞扎或英格瑞扎喷雾剂治疗期间服用某些其他药物，则QT延长的可能性更高。如果您出现QT间期延长的任何体征或症状，包括：心跳快、慢或不规则（心悸）、呼吸急促、头晕或头晕、晕厥或感觉快要晕倒，请立即告知您的医疗保健提供者。。

Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat..

抗精神病药物恶性综合征（NMS）。NMS是一种可能导致死亡的严重疾病。如果你出现这些症状并且没有其他明显原因，请立即致电医疗保健提供者或前往最近的急诊室：高烧、肌肉僵硬、思维问题、脉搏或血压不规则、出汗增加或心跳过快或不均匀。。

Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.

帕金森样症状。症状包括：身体僵硬、流口水、移动或行走困难、保持平衡困难、颤抖或摔倒。

Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

服用英格莉莎或英格莉莎喷雾剂之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否患有肝脏或心脏问题，怀孕或计划怀孕，或正在母乳喂养或计划母乳喂养。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects.

告诉你的医疗保健提供者你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。确保你告诉所有的医疗保健提供者，你正在服用英格丽萨或英格丽萨喷雾剂。服用英格瑞扎或英格瑞扎撒上某些其他药物可能会导致严重的副作用。

Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days..

如果您服用地高辛或服用或服用过单胺氧化酶抑制剂（MAOI）药物，请特别告知您的医疗保健提供者。如果您在过去14天内服用或停止服用MAOI，则不应服用INGREZZA或INGREZZA Spline。。

The most common side effect of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.

INGREZZA或INGREZZA Sprink对迟发性运动障碍患者最常见的副作用是嗜睡和疲倦。

The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.

英格丽莎或英格丽莎喷雾剂对亨廷顿舞蹈病患者最常见的副作用包括嗜睡和疲倦，皮肤上发痒的红色区域（荨麻疹），皮疹以及难以入睡或保持睡眠。

These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

这些并不是INGREZZA或INGREZZA Spread可能产生的所有副作用。打电话给你的医生，询问有关副作用的医疗建议。鼓励您向FDA报告处方药的负面副作用。请访问www.fda.gov/MedWatch或致电1-800-fda-1088。

Dosage Forms and Strengths: INGREZZA is available in 40 mg, 60 mg, and 80 mg capsules. INGREZZA SPRINKLE is available in 40 mg, 60 mg, and 80 mg oral granules in capsules.

剂型和强度：INGREZZA有40毫克，60毫克和80毫克胶囊。英格瑞扎喷雾剂有40毫克、60毫克和80毫克的胶囊口服颗粒。

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

请参阅完整的处方信息，包括盒装警告和药物指南。

About Neurocrine Biosciences, Inc.Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.

。我们致力于为神经、神经内分泌和神经精神疾病患者发现和开发改变生活的治疗方法。

The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

该公司多元化的产品组合包括FDA批准的治疗迟发性运动障碍、与亨廷顿舞蹈病、子宫内膜异位症*和子宫肌瘤*相关的舞蹈病的药物，以及在我们的核心治疗领域的中晚期临床开发中包括多种化合物的强大渠道。

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter) and Facebook.

三十年来，我们将自己独特的见解应用于神经科学以及大脑和身体系统之间的相互联系，以治疗复杂疾病。我们坚持不懈地寻求药物来减轻使人衰弱的疾病和紊乱的负担，因为你值得勇敢的科学。。

(*in collaboration with AbbVie).

（*与AbbVie合作）。

NEUROCRINE BIOSCIENCES, NEUROCRINE, YOU DESERVE BRAVE SCIENCE and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc.

NEUROCRINE BIOSCIENCES，NEUROCRINE，YOU Worth BRAVE SCIENCE和INGREZZA是NEUROCRINE BIOSCIENCES，Inc.的注册商标。NEUROCRINE徽标是NEUROCRINE BIOSCIENCES，Inc.的商标。

Forward-Looking StatementsIn addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA SPRINKLE and the value INGREZZA SPRINKLE may bring to patients.

前瞻性声明除了历史事实外，本新闻稿还包含涉及许多风险和不确定性的前瞻性声明。这些陈述包括但不限于关于INGREZZA Spread的潜在益处以及INGREZZA Spread可能给患者带来的价值的陈述。

Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA SPRINKLE; whether INGREZZA SPRINKLE receives adequate reimbursement from third-party payors; the degree and pace of market uptake of INGREZZA SPRINKLE; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA SPRINKLE; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA SPRINKLE, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA SPRINKLE or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA SPRINKLE; risks that post-approval INGREZZA SPRINKLE commitments or requirements may be delayed; risks that INGREZZA SPRINKLE may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA SPRINKLE; .

可能导致实际结果与前瞻性声明中指出的结果存在重大差异的因素包括：与Neurocrine Biosciences的业务和财务相关的风险和不确定性，以及与INGREZZA Spread商业化相关的风险和不确定性；INGREZZA Spread是否从第三方付款人处获得足够的报销；INGREZZA Spread的市场占有程度和速度；与竞争产品和技术变化相关的风险和不确定性可能会限制对英格瑞扎洒水车的需求；与公司依赖第三方进行与INGREZZA Spread相关的开发和制造活动相关的风险，以及公司管理这些第三方的能力；可能不会发生或无法及时提交针对INGREZZA Spread或其他候选产品的其他监管提交文件的风险；FDA或其他监管机构可能对INGREZZA Spread做出不利决定的风险；批准后INGREZZA Spread承诺或要求可能延迟的风险；INGREZZA Spread可能因第三方的专有权而无法商业化，或产生意外副作用、不良反应或误用事件的风险；与竞争产品和技术变化相关的风险和不确定性可能会限制对INGREZZA Spready；的需求。

REFERENCES

参考文献

INGREZZA capsules [package insert]. San Diego, CA; Neurocrine Biosciences, Inc; 2024.

INGREZZA胶囊[包装说明书]。加利福尼亚州圣地亚哥；Neurocrine Biosciences，Inc；2024

Data on file. Neurocrine Biosciences, Inc.

文件中的数据。Neurocrine Biosciences公司。

*Tardive Dyskinesia Patient ATU 2023. Target patients (diagnosed TD or suspected TD), n = 250.

*迟发性运动障碍患者ATU 2023。目标患者（诊断为TD或疑似TD），n=250。

†Responses based on survey questions: 'Since first experiencing involuntary movements, how has your ability to physically perform the following daily activities been affected, if at all?' and 'How would you describe the severity of your involuntary movements?' Please use a scale of 1 to 5 when 1 means 'Not at all affected' and 5 means 'Extremely negatively affected.' Results shown include the number of responses greater than or equal to 3 on the scale. .

†基于调查问题的回答：“自从第一次经历非自愿运动以来，你的身体进行以下日常活动的能力受到了什么影响以及“你如何描述你不自主运动的严重程度？”当1表示“完全不受影响”，5表示“极度负面影响”时，请使用1到5的量表显示的结果包括量表上大于或等于3的响应数量。。

© 2024 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-3525  07/2024

©2024 Neurocrine Biosciences，Inc.保留所有权利。CP-VBZ-US-3525 2024年7月

SOURCE Neurocrine Biosciences, Inc.

来源Neurocrine Biosciences，Inc。